Are Prenatals Marketed as Unapproved Drugs Exempt from FDA’s September 19 Guidance? No

We recently reported that on September 19th, FDA announced the issuance of a revised version of the Agency’s June 2006 final guidance document/Compliance Policy Guide (“CPG”), titled “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs.” The revised CPGs says that FDA’s risk-based approach to taking enforcement action with respect to the manufacture and distribution of marketed unapproved drugs first articulated in the June 2006 CPG continues to apply today, but only to unapproved drug products on the market as of September 19, 2011. Since FDA issued the revised CPG, at conferences we have attended and in phone calls we have received, companies marketing or planning to market prenatal vitamin products, some of which are marketed as unapproved drugs, have been asking whether the guidance was intended to prevent the marketing of new prenatal products as unapproved drugs.

We received an answer from FDA. The following is a quote from an FDA CDER/Office of Compliance e-mail we received:

Any unapproved drug that enters the market on or after 9/19/11 is subject to immediate enforcement action without prior notice. Any unapproved drug on the market prior to 9/19/11 is subject to the enforcement priorities in the CPG.

Prenatal vitamins are not excepted from this CPG. If firms intend their prenatal vitamins to be marketed as drugs without approval, they are subject to this enforcement policy.

The likely impact of this change of policy on prenatals will be to force new products to be marketed as dietary supplements, which for the most part appears to be a transition that can be made with appropriate label and claim changes, and possibly some formulation changes.